US FDA Drug Review Goals Should Be Faster In PDUFA VII, Industry Negotiators Propose

The US Food and Drug Administration’s review goals would be faster in the next prescription drug user fee cycle if a proposal from industry negotiators is adopted.

Several weeks of talks between sponsor and agency representatives in the PDUFA VII Pre-Market subgroup addressed what were referred to as “Innovative Review Approaches,” among them an industry suggestion to “bring the action date for efficacy supplements, and potentially original applications, earlier to expedite patient access to innovative treatments,” according to recently-released